FDA.reportPublic FDA data

Cefdinir

Product NDC
71205-405
11-digit product format
712050405
Labeler code
71205
Product ID
71205-405_b484ae16-7d8d-4be7-9c9a-2b613592eca3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefdinir
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA065473
Marketing category
ANDA
Marketing start
2007-12-14
Substance
CEFDINIR
Active strength
250 mg/5mL
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cefdinir
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFDINIR250 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCI0FAO63WC
Rxcui476576

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d3e72f63-2c41-955f-f4ce-e90c6403e67cProduct name220210729
e8e66e64-d220-99cb-44eb-0f32dc8cbda1Product name220210729

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-405-00Cefdinir100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1003
71205-405-00Cefdinir1 in 1 CARTONPOWDER, FOR SUSPENSION13
71205-405-60Cefdinir1 in 1 CARTONPOWDER, FOR SUSPENSION13
71205-405-60Cefdinir60 mL in 1 BOTTLEPOWDER, FOR SUSPENSION603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-405-00ML - Milliliter71205-405170aecf1-f064-4ef9-a674-4403c838074112020-04-20
71205-405-60ML - Milliliter71205-4055340133c-6d80-4fa9-a3bd-cd0a05548f5a12020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-405CEFDINIR POWDER, FOR SUSPENSION [PROFICIENT RX LP]3Current NDC, Legacy NDC, 4 package rows20220911_8305b5d8-53b3-475a-b263-07d5fd81392a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476576cefdinir 250 MG in 5 mL Oral SuspensionPSN8305b5d8-53b3-475a-b263-07d5fd81392a3
476576cefdinir 50 MG/ML Oral SuspensionSCD8305b5d8-53b3-475a-b263-07d5fd81392a3
476576cefdinir 250 MG per 5 ML Oral SuspensionSY8305b5d8-53b3-475a-b263-07d5fd81392a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-405-00712050405001 BOTTLE in 1 CARTON (71205-405-00) / 100 mL in 1 BOTTLE1 bottle2020-02-180000-00-00NoNoCurrent
71205-405-60712050405601 BOTTLE in 1 CARTON (71205-405-60) / 60 mL in 1 BOTTLE1 bottle2020-05-280000-00-00NoNoCurrent